QIP Services

The Quality Improvement Program (QIP) offers a variety of human research support services and education to the Harvard Longwood Campus (Harvard Chan School, HMS, HSDM) research community in order to assist investigators and their research staff and facilitate compliance with federal regulations, state and local laws, and institutional policies.  To request any of the services below, please complete the Service Request Form or contact a member of the QIP team directly.

Research Support Services

Study Consultation

At the time of study start-up or throughout the life of a protocol, QIP is available to meet with the research team to help anticipate and resolve regulatory issues that may hinder the IRB review and approval process.

IRB Submission Assistance

To facilitate the IRB review and approval process, QIP is available to aid in drafting or to pre-review IRB submissions, assist with navigation and submission through ESTR, or help respond to questions posed by the IRB.

Routine Onsite Review

At the request of the Principal Investigator or study staff member, QIP is available to conduct both domestic and international onsite review of study documentation to ensure regulatory compliance including protocol adherence, accurate record keeping, and appropriate informed consent process.  During the on-site review, QIP will provide corrective actions and offer quality improvement recommendations.

QIP Education Series

Each academic year, QIP offers a different education series with sessions focusing on various topics including IRB submission requirements, study management, and informed consent process. Those who attend 3 sessions during an academic year will receive Human Research training refresher credit.  Attendance is open to all.  Check out the current Education Series schedule and past presentation slides.


Upon request, QIP staff is available to conduct any size group training sessions on a variety of topics relating to research compliance; institutional and school policy; Good Clinical Practice; Exemptions; Informed Consent; Regulatory Documentation, etc.  These sessions are developed to meet the specific needs of the study site. Depending on the depth and length of the In-service, attendees may earn Human Research training credit for their participation.

One-on-One Study Staff Orientation

Upon request, QIP is available to meet with new study staff (PIs, Coordinators, etc.) in order to familiarize them with ORARC policies and procedures including the IRB review and approval process.  Participants will learn about available human research support services and study management tools.

Study Management Tools

QIP offers a variety of easy-to-use study management tool templates to assist research sites in maintaining and organizing essential study documents.  These tools can be downloaded and tailored to your specific study needs.  Submit your request for a new tool here.  If you would like for QIP to customize one of our existing tools to fit your study needs complete a Service Request Form.

Grant Review: Human Subjects Sections

Enlist the QIP staff to review and edit the language that you have drafted for the human subjects sections of your grant application study records to ensure that they properly identify and address all the necessary human subjects concerns.

Floating Research Coordinator/Project Manager Support

Obtain temporary floating research coordinator/project manager support for assistance in the implementation of HLC IRB-approved protocols at no cost.  Research Coordinators/Project Managers are Certified IRB Professionals who have an in-depth understanding of both institutional policies and federal regulations. They are available to provide short or long-term coverage for a variety of research related services, including recruitment, obtaining consent, and study management.

This service is subject to availability of QIP Staff for the specified amount of time.